Answers
02/20/1992

<TITLE>PANEL MAKES BREAST IMPLANT RECOMMENDATIONS</TITLE>
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T92-9                                                 Susan Cruzan
Feb. 20, 1992                                         (301) 443-3285

                 PANEL MAKES BREAST IMPLANT RECOMMENDATIONS

    FDA's General and Plastic Surgery Devices Panel has recommended limited   
availability for silicone gel-filled breast implants under carefully          
controlled clinical protocols.  The panel also recommended that FDA advise    
women who already have the implants to have them checked regularly by their   
physicians.
    The following may be used to answer questions:
    The outside advisory panel, which met Feb. 18-20, heard testimony from    
doctors, companies and consumers on benefits and problems associated with     
these devices, which have been implanted in an estimated one million women    
for breast augmentation or for reconstruction.  
    In making its recommendations, the panel cited a special medical need     
for women with breast cancer and certain other conditions, while expressing   
a concern about the risks represented by the implants.  For this reason,      
members decided to permit use of the implants under clinical protocols that   
would allow access to all women requiring reconstruction who need silicone    
gel implants.  They recommended only limited trials to study women who        
choose the implants for augmentation purposes.  The number of augmentation    
patients to be studied will be determined by the nature of the scientific     
questions being asked.  
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                                            Page 2, T92-9, Breast Implants
    The panel also advised women with implants to see their physicians        
regularly and, if an implant is found to have ruptured, to have it removed.   
It did not recommend that women with implants who have no symptoms undergo    
routine mammography just to look for a rupture.  The panel did advise that    
these women follow established cancer screening recommendations.  The panel   
noted that it is especially important that women inform the mammography       
facility that they have implants so that special techniques can be used by    
personnel trained in examining women with breast implants.  Whenever          
possible they should seek a facility accredited by the American College of    
Radiology.
    While it considered the possible link between certain immune-related or   
connective tissue disorders and the implants, the panel said there were       
insufficient data to reach a conclusion on this matter.
    The panel's recommendations are not binding on the agency but will be     
carefully considered by FDA in reaching a decision.  FDA Commissioner David   
A. Kessler, M.D., pledged to make a decision on the implants within 60 days,  
by April 20.  Dr. Kessler had called for a moratorium on distribution and     
use of the implants on Jan. 6.  The moratorium will remain in effect until    
FDA makes a decision.
    Consumers wishing more information about breast implants and panel        
recommendations may call 1-800-532-4440, Mon. through Fri., 9 a.m. to       
7 p.m., Eastern Standard Time.
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